Events

Alerta De Seguridad para EXTENSOR FOR RESONANCE AND TOMOGRAPHY (RT12000V) - Registration No. 10216839006 - Batches 11E03; 11D27; 11D28; 11C18 ### SMARTSITE GABMED VALVE EXTENSOR (GB71230) - Registration No. 10216830035 - Batches 11G09; 12A21; 12C14 ### EXTENSOR FOR RESONANCE AND TOMOGRAPHY (RT12200) - Registration No. 10216830048 - Lots 11E11; 11F05; 11F18 ### EXTENSOR WITH GABMED MULTIVALVULATED TAP (GB61222) - Registration No. 10216830052 - Batches 11E04; 11F06 ### INFUSION EQUIPMENT WITH GABMED VALVULATED SIDE INJECTOR (RT12400) - Registration No. 10216830046 - Lot 12B13.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por GaBmed Produtos Específicos Ltda..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1191
  • Fecha
    2012-10-08
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notas adicionales en la data
    The component used for connection (Y connector) was produced in flexible PVC and did not generate mechanical resistance (hardness) with the other components of the product when being glued, being possible cracks in the component body or leakage in the thread.
  • Causa
    Product leaks on your connection.
  • Acción
    Observe the integrity of the product before use. If the product shows the quality deviation mentioned above, immediately inform the responsible manufacturer or distributor.

Device

EXTENSOR FOR RESONANCE AND TOMOGRAPHY (RT12000V) - Registration No. 10216839006 - Batches 11E03; ...

Manufacturer

GaBmed Produtos Específicos Ltda.